We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results:1-10 of 53

Implemention of “Bolar” in the EU
  • Gowling WLG
  • United Kingdom, European Union
  • October 31 2007

In Europe, Directive 200427EC (amending Directive 200183EC) introduced into European Union legislation for the first time an exemption from patent infringement for conducting certain developmental work pre-patent expiry (the EU ‘Bolar’ exemption).


Data protection in Canada: too much? Too little?
  • Gowling WLG
  • Canada
  • June 28 2011

Prior to the enactment in 2006 of the amendments to section C.08.004.1 of the Food and Drugs Regulations (Data Protection Regulations), Canada did not have an effective regime of data protection exclusivity.


The Pharmaceutical Sector Inquiry Preliminary Report: patent-related issues raised relevant to all patent intensive industries
  • Gowling WLG
  • United Kingdom, European Union
  • January 29 2009

Wragge & Co's first analysis of the EU Commission's preliminary report on the pharmaceutical sector looked at the regulatory issues covered by the preliminary report.


Board follows guidelines in Penlac decision
  • Gowling WLG
  • Canada
  • February 7 2011

On February 3, 2011, the Patented Medicine Prices Review Board (the Board) released its decision dated January 31, 2011, regarding Penlac, a drug manufactured by sanofi-aventis.


New regulations respecting benefits and promotional allowances in Québec
  • Gowling WLG
  • Canada
  • November 16 2007

The Government of Québec has introduced new regulations under the Act Respecting Prescription Drug Insurance governing the rebates and other benefits offered by drug manufacturers to pharmacists.


Court challenge to CADTH actions
  • Gowling WLG
  • Canada
  • March 3 2009

The Ontario Superior Court of Justice (Divisional Court), on October 16, 2008, decided a case involving a challenge to the Canadian Agency for Drugs and Technologies in Health (CADTH), the non-profit corporation that reviews medicines and technologies and makes recommendations to provincial governments and agencies as to which drugs should be listed (ie., paid for) by provincial government drug plans.


Apotex Inc v. Richter Gedeon Vegyeszeti Gyar Rt
  • Gowling WLG
  • Canada
  • August 25 2010

Plaintiff distributor of pharmaceuticals commenced an action for delayed market entry against Defendant manufacturers of pharmaceuticals for various losses.


Health Canada releases final guidance on biosimilars
  • Gowling WLG
  • Canada
  • March 25 2010

On March 8, 2010, Health Canada released its final guidance documents relating to the approval pathway for subsequent entry biologics (SEBs) in Canada.


A balancing act: innovation and the regulatory-approval exemption
  • Gowling WLG
  • Canada
  • April 22 2013

In the pharmaceutical sector, patent systems are concerned with balancing the interests of innovator drug companies, the public and generic


U.S. FDA contemplates new rules for internet-delivered health information
  • Gowling WLG
  • USA
  • December 3 2009

In recognition of the increasing use of the Internet by consumers for health-related information, the FDA is seeking to determine whether it needs to regulate the promotion of drugs and medical devices on the Internet.